Elisa Newkirk
Quality Systems Management Director | GMP, GLP, GCP | Biologics, Biotherapeutics, Pharmaceuticals | Stability | Project Quality Management
- Role
- Qa Director of Facilities & Compliance at KBI Biopharma
- Location
- Raleigh, NC, US
- LinkedIn followers
- 500 followers
About Elisa Newkirk
Experienced pharmaceutical leader in quality systems for biological therapeutics manufacturing, driving compliance, innovation, and global impact. Proven in robust frameworks, seamless inspections, and empowering teams for transformative outcomes. I am passionate about delivering quality products that improve the lives of patients and contribute to the advancement of biotechnology. I am looking for an opportunity to join a dynamic and innovative team that shares my vision and values of excellence, integrity, and collaboration.
Experience
Qa Director of Facilities & Compliance
Oct 2023 — Present · Research Triangle Park, NC, US
Education
Campbell University
Master of Science (MS), Clinical Research
2004 — 2006
North Carolina State University
BS, Microbiology
1994 — 1996
Skills
- Sds-Page
- 21 Cfr Part 11
- Cgmp Manufacturing
- Sop
- Chromatography
- Computer System Validation
- Formulation
- Life Sciences
- Aseptic Technique
- Change Control
- Microbiology
- Validation
- Corrective and Preventive Action (Capa)
- Aseptic Processing
- Lyophilization
- V&V
- Elisa
- Cgmp Practices
- Purification
- Capa
- Bioanalysis
- Pharmaceutical Industry
- Stability
- Biotechnology
- Hplc
- Fda Gmp
- Glp
- Lims
- Trackwise
- Biopharmaceuticals
- Gmp
- Downstream Processing
- Technology Transfer
- Gamp
- Cleaning Validation
- Sterilization
- Good Laboratory Practice (Glp)
- Fda
- Protein Chemistry
- Regulatory Affairs
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